# K123347: Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Normed Medizin-Technik GmbH
- Decided: Aug 2, 2013 after 275 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010612 (2001). 92 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022324: Normed Titanium Calcaneus Plating with Locking Screw System, Osteomedics, Inc. (2002) Summary page 1.
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates, Smith & Nephew, Inc. (2011) Summary page 2.
- K100176: Ascension Ankle Fusion Plate System, Ascension Orthopedics, Inc. (2010) Summary page 2.

## Most influential descendants
- K212640: Stratum® Ankle Fusion Plating System (2021), 0 descendants of its own
- K203479: ExtremiLOCK Lateral Ankle Fusion Plates (2021), 0 descendants of its own

## Recalls of this device
- Apr 8, 2019 · Class II · Z-1433-2019: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- Apr 8, 2019 · Class II · Z-1451-2019: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

## Indications for use
ANKLE FIX and ANKLE FIX + Systems 4.0 are indicated for: skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis primary or revision tibio-talar and tibiotalo-calcaneal fusion especially in the presence of osteopenic bone, hindfoot deformity and bone loss post-traumatic surgery.

Source page: https://510kreport.com/device/K123347
Methodology: https://510kreport.com/methodology